Medical device

ABSTRACT

Apparatuses of the type broadly applicable to numerous medical applications in which it is desirable to insert one or more steerable or non-steerable catheters or similar devices into a working channel of an associated device, such as an endoscope, catheter, etc., or passageway of a patient, are disclosed. The apparatuses may include catheters having a dedicated guide wire channel and one or more of the following: viewing capabilities, a working channel, and auxiliary channels, such as insufflation/irrigation channels. The catheters may include a guide wire channel that is configured to provide the catheter or other device with rapid exchange capabilities.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/021,003, filed Jan. 14, 2008, the disclosure of which is herebyincorporated by reference.

BACKGROUND

A challenge in the exploration and treatment of internal areas of thehuman anatomy has been adequately visualizing the area of concern.Visualization can be especially troublesome in minimally invasiveprocedures in which small diameter, elongate instruments, such ascatheters and endoscopes, are navigated through natural passageways of apatient to an area of concern either in the passageway or in an organreachable through the passageway.

Detailed information regarding the anatomy can be discerned from directviewing of the anatomy provided through one or more of the elongateinstruments used in the procedure. Various types of endoscopesconfigured for use in various passageways of the body such as theesophagus, rectum or bronchus can be equipped with direct viewingcapability through the use of optical fibers extending through thelength of the scope, or with digital sensors, such as CCD or CMOS.However, because endoscopes also provide a working channel through whichother medical instruments must pass, optional lighting bundles andcomponents to provide steering capability at its distal end, the scopeis typically of a relatively large diameter, e.g., 5 mm or greater. Thislarge diameter limits the use of the endoscope to relatively large bodychannels and prohibits their use in smaller ducts and organs that branchfrom a large body channel, such as the biliary tree.

Typically, when examining small passageway such as the bile duct orpancreatic duct, the endoscope is used to get close to a smallerpassageway or region of concern and another instrument, such as acatheter, is then extended through the working channel of the endoscopeand into the smaller passageway. The catheter can be routed over a guidewire pre-placed in the area of interest. Alternatively, a catheter ofthe steerable type may be steered into the smaller passageway with theaid of images provided from the endoscope, or if the steerable catheterhas its own vision capabilities, steered into the smaller passagewaywith the aid of images provided by the catheter. One such steerablecatheter with vision capabilities is described in co-pending U.S.application Ser. No. 11/089,520, filed Mar. 23, 2005, which is herebyincorporated by reference. Once the catheter is in the small passageareas, visualization may be provided via contrast media and/or thevision capabilities of the catheter.

Visualization may reveal selected areas within the area of interest,such as the common bile duct, that require treatment. To treat theselected areas, a different catheter is sometimes required,necessitating a catheter exchange. A catheter exchange typicallyinvolves removing the first catheter from the endoscope over a guidewire pre-placed in the area of interest, and advancing a second catheterover the guide wire to the desired treatment site. In order to maintaina handle on the proximal end of the guide wire, it is necessary that theportion of the guide wire that remains outside the patient be longerthan the length of the catheter. Therefore, a catheter/guide wire systemsuitable for these procedures has required the use of long guide wiresthat can be cumbersome to manipulate and can clutter an operating room.

To address the issues associated with changing catheters over long guidewires, many non-steerable catheters include so-called “rapid exchange”lumens or channels. These rapid exchange catheters typically include anopening on the sheath of a catheter and a slot that extends along thelength of the catheter through which a guide wire can be pulled. Toexchange the catheter for another device while maintaining the positionof the guide wire in the body, the catheter is stripped off the guidewire by pulling it through the slot. A new catheter or device can thenbe routed over the guide wire by inserting the proximal end of the guidewire into an opening of a guide wire lumen at the distal end of the newdevice and advanced such that the proximal end of the guide wire exitsthe opening. The opening may be positioned towards the proximal end ofthe catheter or may be located more towards the distal end.

While rapid exchange guide wire lumens have been developed for manyprocedures, they have not been adapted for use with steerable catheters,catheters with vision capabilities, catheters to be routed through theworking channels of endoscopes, or catheters that are required totransmit torque from the proximal to the distal end of the catheter.

In addition to performing a catheter exchange procedure, it may also bedesirable to perform a guide wire exchange procedure. This may bedesirable when, for example, a first guide wire is too large to fitthrough a desired body duct, or otherwise lacks the desiredcharacteristics. Under these circumstances, a physician may leave thecatheter in place, withdraw the first guide wire from the catheter, andinsert a second guide wire through the catheter to the desired site.During this procedure, the catheter guides the guide wire to the desiredsite. Thus, once the catheter is positioned at a target site, it ishighly desirable to maintain the position of the catheter during a guidewire exchange procedure so that the second guide wire may be guideddirectly to the desired site in a minimum amount of time.

SUMMARY

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This summary is not intended to identify key features ofthe claimed subject matter, nor is it intended to be used as an aid indetermining the scope of the claimed subject matter.

In accordance with aspects of the present invention, a catheter isprovided which comprises an elongated shaft having a proximal end and adistal end, a guide wire channel extending along at least a portion ofthe shaft in-between the proximal and distal ends, at least one channeldisposed within the shaft and extending to the distal end, and a guidewire opening disposed in communication with the guide wire channel ofthe shaft such that a guide wire may be insertable into the guide wireopening and routed into the guide wire channel. The shaft may beconfigured for providing radial access from a position exteriorly of theshaft to a portion of the guide wire channel that extends between theguide wire opening and a position proximal the distal end of the shaftin order to allow a guide wire to radially exit the shaft.

In accordance with another aspect of the present invention, a catheteris provided which comprises an elongated shaft having a proximal sectionand a distal section, a channel for accessing the distal end of theshaft, a guide wire channel extending along at least a portion of theshaft to the distal end of the shaft, and a guide wire port disposed ator near the transition between the proximal section and the distalsection of the shaft. The guide wire port defines a guide wire portopening and a guide wire port conduit that communicate with the guidewire channel of the shaft such that a guide wire may be insertable intothe guide wire port opening and routed into the guide wire channel. Thecatheter further comprises a deflector associated with the guide wireport and positionable in the guide wire conduit or the guide wirechannel.

In accordance with another aspect of the present invention, a catheteris provided which comprises an elongated shaft having a proximal end anda distal end, a guide wire channel extending along at least a portion ofthe shaft in-between the proximal and distal ends, at least one opticalchannel disposed within the shaft and extending to the distal end, aguide wire opening disposed in communication with the guide wire channelof the shaft such that a guide wire may be insertable into the guidewire opening and routed into the guide wire channel, and means disposedalong a portion of the shaft for allowing a guide wire to radially exitthe shaft.

In accordance with another aspect of the present invention, a catheteris provided which comprises an elongated shaft having a proximal end anda distal end, wherein the elongated shaft comprises an core body anouter sleeve, and an inner reinforcement sheath disposed between thecore body and the outer sleeve. The catheter further includes a guidewire channel extending along at least a portion of the shaft in-betweenthe proximal and distal end, a guide wire opening disposed incommunication with the guide wire channel of the shaft such that a guidewire may be insertable into the guide wire opening and routed into theguide wire channel, and means disposed along a section of the shaft forallowing a guide wire to radially exit the shaft, wherein the means isdisposed outwardly of the inner reinforcement sheath for at least afirst portion of the section of the shaft and disposed inwardly of theinner reinforcement sheath for at least a second portion of the sectionof the shaft.

In accordance with another aspect of the present invention, a catheteris provided which comprises an elongated shaft having a proximal end anda distal end. The shaft has a proximal section having a first diameterand a distal section having a second, smaller diameter. The catheterfurther includes a guide wire channel extending along a portion of theshaft in-between the proximal and distal end, at least two channelsselected from the group consisting of a working channel, an opticalchannel, and a fluid channel, disposed within the shaft and extending tothe distal end, and a guide wire opening disposed in communication withthe guide wire channel of the shaft such that a guide wire may beinsertable into the guide wire opening and routed into the guide wirechannel, wherein the shaft includes a rapid exchange channel sectionalong a portion thereof.

DESCRIPTION OF THE DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same become betterunderstood by reference to the following detailed description, whentaken in conjunction with the accompanying drawings, wherein;

FIG. 1 is a plan view of an exemplary embodiment of a catheter assemblyformed in accordance with aspects of the present invention;

FIG. 2 is a cross-sectional view taken along line 2-2 in FIG. 1;

FIG. 3 is a cross-sectional view taken along line 3-3 in FIG. 1;

FIG. 4 is a cross-sectional view taken along line 4-4 in FIG. 1;

FIG. 5 is a perspective view of one exemplary embodiment of a guide wireport formed in accordance with aspects of the present invention;

FIG. 6 is a cross-sectional view of the guide wire port of FIG. 5;

FIG. 7 is a plan view of an exemplary embodiment of a catheter formed inaccordance with aspects of the present invention;

FIG. 8 is a cross-sectional view taken along line 8-8 in FIG. 7;

FIG. 9 is a cross-sectional view taken along line 9-9 in FIG. 7;

FIG. 10 is a plan view of another exemplary embodiment of a catheterassembly formed in accordance with aspects of the present invention;

FIG. 11 is an end view of a catheter of the catheter assembly shown inFIG. 10, wherein a catheter of the catheter assembly is inserted into aworking channel of an endoscope;

FIG. 12 is a partial perspective view of the catheter shown in FIGS. 10and 11;

FIG. 13 is a partial side cross-sectional view of one exemplaryembodiment of a guide wire port formed in accordance with aspects of thepresent invention;

FIG. 14 is a plan view of another exemplary embodiment of a catheterassembly formed in accordance with aspects of the present invention;

FIG. 15 is a cross-sectional view taken along line 15-15 in FIG. 14;

FIG. 16 is a cross-sectional view taken along line 16-16 in FIG. 14;

FIG. 17 is a partial perspective view of a taper or transition sectionformed in accordance with aspects of the present invention;

FIGS. 18A-18D are cross-sectional views of exemplary embodiments of thecatheter; and

FIGS. 19A-19D are cross-sectional views of additional exemplaryembodiments of the catheter.

DETAILED DESCRIPTION

Embodiments of the present invention will now be described withreference to the drawings where like numerals correspond to likeelements. Embodiments of the present invention are directed toapparatuses of the type broadly applicable to numerous medicalapplications in which it is desirable to insert one or more steerable ornon-steerable catheters or similar devices into a working channel of anassociated device, such as an endoscope, catheter, etc., or passagewayof a patient. Embodiments of the present invention are generallydirected to features and aspects of a catheter having a dedicated guidewire channel and one or more of the following: viewing capabilities, aworking channel, and auxiliary channels, such as insufflation/irrigationchannels. In embodiments of the present invention, the guide wirechannel may be configured to provide the catheter or other device withrapid exchange capabilities.

As will be described in detail below, the catheter may obtain viewingcapabilities for viewing anatomical structures within the body by beingconstructed as a vision catheter or by having a fiberscope or otherviewing device selectively routed through one of its channels. As such,embodiments of the present invention can be used for a variety ofdifferent diagnostic and interventional procedures. The catheter may beof the steerable type so that the distal end of the catheter may besteered from its proximal end as it is advanced within the body or ofthe non-steerable type. A suitable use for the catheters describedherein includes, but is not limited to, diagnosis and/or treatment ofthe duodenum, and particularly the biliary tree.

Although exemplary embodiments of the present invention may be describedhereinafter as suitable for use with duodenoscopes, it will beappreciated that embodiments of the present invention and aspectsthereof have wide application, and may be suitable for use with otherendoscopes (e.g., ureteroscopes) or medical devices, such as catheters(e.g., guide catheters, electrode catheters, angioplasty catheters,etc.). Accordingly, the following descriptions and illustrations hereinshould be considered illustrative in nature, and thus, not limiting thescope of the present invention. Additionally, embodiments of thecatheter may be utilized alone, as well as in conjunction with aconventional endoscope.

Referring now to FIG. 1, there is shown a representative embodiment of acatheter assembly, generally designated 20, formed in accordance withaspects of the present invention. In the embodiment of FIG. 1, thecatheter assembly 20 includes a catheter handle 22, a catheter 24, andan optional guide wire port 26 positioned along a portion of thecatheter 24. The catheter 24 includes a proximal end 30 that may beoperatively connected to the catheter handle 22 and a distal end 32 thatmay be inserted into, for example, a working channel of an endoscope,such as a duodenoscope, or a passageway of a patient. The catheter 24 asshown includes a shaft 36 comprising a proximal section 40, a distalsection 44, and an optional taper 48, which acts as a transition betweenthe proximal section 40 and the distal section 11 of the catheter 24.

In the embodiment shown, the proximal section 40 has a largercross-sectional area, e.g., diameter, than the distal section 44,although in other embodiments, the proximal section 40 and the distalsection 44 may have the same generally uniform cross-sectional area. Assuch, the taper 48 may be omitted in these latter embodiments. Thecatheter 24 may further be of the steerable or deflectable type, andthus, the distal section 44 may either include an articulating sectionor may be constructed of a more flexible material than the proximalsection 40 for aiding in the deflection of the distal end 32.

Referring now to FIGS. 2-4, one exemplary embodiment of the cathetershaft 36 is shown in more detail. FIGS. 2-4 are cross-sectional views ofthe proximal section 40 taken proximally and distally of the guide wireport 26 and of the distal section 44, respectively. As best shown inFIGS. 2-4, the catheter shaft 36 includes a dedicated guide wire channel60 and one or more channels 62, 64, and 66 for providing access to atreatment area located at the distal end of the catheter.

In the embodiment shown in FIGS. 2-4, the dedicated guide wire channel60 extends the entire length of the catheter through which a guide wirecan be routed to and from the treatment area. In other embodiments, theguide wire channel 60 may not extend the entire length of the cathetershaft but instead extends only a portion thereof, for example, from oneof many positions located distally of the proximal end to the catheterdistal end. As will be described in more detail below, a portion of thecatheter shaft is slitted, slotted or otherwise configured to provideaccess along the catheter shaft 36 for providing rapid exchangecapabilities to the catheter.

The one or more channels 62, 64, and 66 may extend from a positionproximal of the distal end of the catheter shaft 36. For example, theone or more channels 62, 64, and 66 may extend to the distal end of thecatheter shaft 36 from either the proximal end of the catheter or aposition proximal of the catheter distal end.

As best shown in FIGS. 2-4, the one or more channels may include anoptical channel 62. The optical channel 62 allows for the passage of afiberscope, optical fiber cable, optical assembly, or other smalldiameter viewing catheter or device to the distal end of the catheter.In other embodiments, a fiberscope, optical fiber cable or the like maybe permanently secured in place within the channel. Alternatively, thecatheter 24 may be constructed as a video catheter, and as such, viewingcapabilities are provided by an image sensor, such as a CCD, CMOS, orphoto diode, mounted at or adjacent the distal end of the catheter 24.In this embodiment, the catheter may include other components, such asillumination sources, e.g., LEDs, etc., and associated power and signaltransmission cabling, etc. It will be appreciated that in thisembodiment, the optical channel may be used to provide a source ofillumination to the distal tip by routing an illumination fibertherethrough, or such optical channel may be omitted.

The one or more channels may also include a working channel 64. Theworking channel 60 allows for the passage of various treatment ordiagnostic devices, such as stone retrieval baskets, lasers, biopsyforceps, etc. to and from the treatment area located distally of thecatheter distal end. The one or more channels may further include anadditional channel 66 for use as an irrigation/insufflation channel, afluid delivery channel, or multi-purpose channel. The channel 66 allowsthe passage of liquids, gases, and/or device to and from the treatmentarea.

As was described briefly above, in several embodiments of the presentinvention, the catheter 24 may be of a steerable-type, and thus, thecatheter shaft 36 may optionally include one or more steering wirechannels 70 that extend substantially the length of the catheter 24 fordeflecting the distal end of the catheter shaft 36 in one or moredirections. In the embodiment shown in FIGS. 2-4, steering wires 72 canbe routed through a corresponding number of steering wire channels 70,extend from the distal end of the catheter to the opposing, proximal endof the catheter, and terminate in a suitable manner with a steeringmechanism associated with the catheter handle 22, as will be describedin detail below. The steering wires 72 may be attached at anchor pointsto the distal section near or at the distal end of the catheter viaconventional techniques, such as adhesive bonding, heat bonding,crimping, laser welding, resistance welding, soldering, etc., such thatmovement of the wires causes the distal end to deflect in a controllablemanner. In one embodiment, the steering wires 72 are attached viawelding or adhesive bonding to a fluoroscopy marker band (not shown)fixedly attached to the distal section. In this embodiment, the band maybe held in place via adhesive and/or an outer sleeve.

The steering wires 72 preferably have sufficient tensile strength andmodulus of elasticity that they do not deform (elongate) during curveddeflection. In one embodiment, the steering wires are made from 304stainless steel with an 0.008 inch diameter and have a tensile strengthof approximately 325 KPSI. The steering wires 72 can optionally behoused in a PTFE thin-walled extrusion (not shown) to aid in lubricityand prevent the catheter 24 from binding up during deflections, ifdesired. For a more detailed description of types of steering wires andcatheter shaft configurations that may be practiced with the presentinvention, please see co-pending U.S. application Ser. No. 11/089,520,which is hereby incorporated by reference.

In the illustrated embodiment shown in FIGS. 2-4, the catheter 24includes two pairs of steering wires 72 that controllably steer thecatheter 24 in two substantially perpendicular planes. In alternativeembodiments, the catheter 24 includes one pair of steering wires 72 thatallow the user to steer the distal end in one plane. In a furtherembodiment, the catheter 24 only includes one steering wire 72 thatallows the user to steer the distal end in one direction. In anotherembodiment, the steering wires may be omitted, and thus, the catheter 24can be of a non-steerable type. In such an embodiment, the catheter canbe advanced over a guide wire (not shown) pre-placed, for example, inthe bile or pancreatic duct (referred in the art as “back loading” thecatheter).

The dedicated guide wire channel 60, the one or more channels 62, 64,and 66, and the optional steering channels 70 may be separate tubularmembers, which are routed. through a tubular catheter shaft.Alternatively, in the embodiment shown in FIGS. 2-4, the catheter shaft36 may comprise a core body 80 that defines the dedicated guide wirechannel 60, the one or more channels 62, 64, and 66, and the optionalsteering wire channels 70. In this embodiment, the core body 80 of thecatheter shaft 36 may be constructed from any suitable material, such asPebax® (polyether block amides), nylon, polytetrafluoroethylene (PTFE),polyethylene, polyurethane, fluorinated ethylene propylene (FEP),thermoplastic elastomers and the like, or combinations or blendsthereof. The core body 80 of the catheter shaft 36 may be formed as aone-piece design using known techniques in the art, such as extrusion,or may be formed in multiple segments, for example, multiple extrudedsections, using one or more materials, which are then subsequentlyjoined by heat bonding, adhesive bonding, lamination or other knowntechniques.

The embodiment of the catheter shaft 36 shown in FIGS. 2-4 mayoptionally include an outer sleeve 82. The outer sleeve 82 may extendthe length of the catheter or sections thereof. The outer sleeve 82 maycomprise one of any number of polymer jackets that are laminated,co-extruded, heat shrunk, adhesive bonded, or otherwise attached overthe core body 80. Suitable materials for the sleeve 82 include, but arenot limited to, polyethylene, nylon, Pebax® (polyether block amides),polyurethane, polytetrafluoroethylene (PTFE), and thermoplasticelastomers to name a few. The outer sleeve 82 may be used to vary thestiffness of the catheter, if desired, or to provide improved torquetransfer and/or other desirable catheter properties. Additionally, thesleeve 82 may be used as one convenient method for securing a moreflexible distal section 44 to the proximal section 40.

In several embodiments, the external surface of the sleeve 82 may have ahydrophilic coating or a silicon coating to ease the passage of thedevice in-vivo. Such a hydrophilic coating can be, for example, but notlimited to, N-Vinyl Pyrrolidone, Poly Vinyl Alcohol, and Poly VinylPyrrolidone. The hydrophilic coating can be accomplished by coating thedevice with a primer, such as Bayhydrol 110 (an anionic dispersion of analiphatic polyester urethane resin in water/n-methyl-2pyrrolidone) andthen bonding the primary layer over the primer. The primary layer canbe, for example, but not limited to, an acrylamide or apolyurethane-based acrylamide. Alliphatic polyether and polyesterpolyurethanes also can be used as lubricous coatings.

In the embodiment shown in FIGS. 2-4, the outer sleeve 82 disposed onthe proximal section 40 is thicker than the outer sleeve 82 disposed onthe distal section for increasing the stiffness and torsional rigidityof the proximal section 40 of the catheter shaft 36. In anotherembodiment shown in FIGS. 7-9, the diameter of the core body 80 of theproximal section 40 is greater than the diameter of the core body 80 ofthe distal section 44 while the outer sleeve 82 is somewhat uniform inthickness as it extends from the beginning of the proximal section 40 tothe end of the distal section 44. In this embodiment, the larger corebody of the proximal section increases the stiffness and/or torsionalrigidity of the shaft.

In other embodiments, the catheter 24 may optionally include an innerreinforcement sheath 84 disposed between the core body 80 and the outersleeve 82 along the distal section 44 (see FIG. 1) of the catheter shaft36 as shown in cross-section in FIG. 4. The sheath 84 may be a woven orlayered structure, such as a braided design of fine wire or polymericelements (0.001 inches to 0.010 inches in diameter) woven or coiledtogether along the longitudinal axis of the catheter with conventionalcatheter braiding techniques. This allows the distal section of thecatheter to be advanced to the desired anatomical site by increasing thecolumn strength of the distal section while also increasing itstorsional rigidity. Conventional coiled polymer or braid wire may alsobe used for this component with coil wire dimensioning ranging in widthfrom 0.002 to 0.120 inches and thicknesses from 0.002 to 0.10 inches.Braided ribbon wire may also be used for the sheath. In one embodiment,the outer sleeve 82 is coextruded, coated, or otherwise attached, oncethe reinforcement layer 84 is applied to the distal section, to lock thereinforcement layer in place and secure it to the distal section corebody 80. In one embodiment, the portion of the proximal section thatextends from the proximal end to the beginning of the guide wire openingmay also include a reinforcement sheath.

Turning now to FIGS. 5 and 6, the catheter shaft 36 may also include anopening 76 formed along a portion of the outer surface of the shaft 36and positioned proximal the distal section 44. The opening 76 is formedso as to communicate with the guide wire channel 60 from a positionexternal the shaft. Referring to FIG. 1, the shaft opening (hidden bythe guide wire port 26) may be positioned proximate or near the proximalend 30 of the catheter 24 or may be disposed further distally of theproximal end 30 along the catheter 24 toward the optional taper 48.Although it should be recognized that the shaft opening may be locatedat any location distally of the proximal end 30 of the catheter 24, inone embodiment the shaft opening is located approximately between 140and 180 centimeters (cm) from the taper 48 and/or the beginning of thedistal section 44. In this manner, the catheter 24 may be utilized witha 260 cm or similar guide wire, as will be described in detail below. Aswill be described in detail below, the shaft opening 76 (FIGS. 5 and 6)in one embodiment communicates with the guide wire port 26 forfacilitating the insertion of a guide wire into the guide wire channelduring use.

Returning to FIGS. 5 and 6, the catheter shaft 36 may further include aslit, a slot, or other means for allowing a guide wire to radially exitthe guide wire channel 60 along a portion of the shaft 36, therebyproviding rapid exchange capabilities to the catheter. In theillustrated embodiment of FIGS. 5 and 6, the catheter shaft 36 includesa slot 78 that connects the guide wire channel 60 to the exterior of theshaft for allowing a guide wire to radially exit the guide wire channel60. The slot 78 extends from the shaft opening 76 to a position distallythereof, such as the beginning of the optional taper or catheter distalsection. As best shown in the embodiment of FIG. 3, the slot 78 isformed in the core body 80 and the optional outer sleeve 82 of thecatheter shaft 36. In embodiments that do not include an outer sleeve,the slot 78 is formed in the core body. As such, the slot 78 and theguide wire channel 60 together define a slotted channel section. Theslotted channel section may define, for example, a general U or C-shapedchannel, although other slotted configurations may be practiced with thepresent invention, and are contemplated to be within the scope of thepresent invention, as claimed.

In use, the slotted channel section serves to contain, but notconstrain, a guide wire as it is routed between the opening 76 and thebeginning of the distal section 44. The guide wire channel 60 issufficiently large to allow unhindered radial guide wire movementtherein. In the embodiment of FIG. 3, the slot 78 is sized to allowpassage of a conventional guide wire (e.g., 0.025 inch-0.035 inchdiameter guide wires) radially therethrough. In several embodiments, theslot 78 is substantially equal to or slightly larger than the diameterof the guide wire channel 60. In other embodiments, the slot 78 may besmaller than the diameter of the guide wire channel 60, as shown, forexample, in FIG. 3. In yet other embodiments, the slot may be smallerthan the diameter of the guide wire routed therethrough, as shown in theexample of FIG. 15. In these embodiments, the slotted channel section isconfigured to allow separation at the opening to the guide wire channelto promote radial passage of the guide wire.

While the embodiments shown in FIGS. 3, 5, and 6 employ a slottedconfiguration for allowing a guide wire to radially exit the guide wirechannel 60, other configurations are contemplated to be within the scopeof the present invention, as claimed. For example, instead of a portionof the slot 78 being formed in the outer sleeve 82, the outer sleeve 82may be formed with a slit with abutting edges, a flap with overlappingedges or interlocking edges, as shown in FIGS. 18A-18C, respectively.Alternatively, as shown in. FIG. 18D, a layer of material of the outersleeve disposed in-between the guide wire channel 60 and the exterior ofthe shaft may be relatively thin, weakened to promote tearing,perforated, or is composed of a generally soft material for providing aweak wall through which a guide wire can be pulled.

FIGS. 19A-19D illustrate other exemplary configurations for allowing aguide wire to radially exit the guide wire channel 60. In theseexamples, the outer sleeve has been omitted. As best shown in FIGS.19A-19C, the catheter shaft 36 may be formed with a slit with abuttingedges, a flap with overlapping edges or interlocking edges,respectively. Alternatively, as shown in FIG. 19D, a layer of materialdisposed in-between the guide wire channel 60 and the exterior of theshaft may be relatively thin, weakened to promote tearing, perforated,or is a generally soft material for providing a weak wall through whicha guide wire can be pulled. In this regard, these aforementionedsections, along with the slotted channel section described above, may bereferred herein as rapid exchange channel sections of the cathetershaft.

Returning to FIG. 1, the catheter assembly 20 may further include aguide wire port 26 positioned, for example, along a portion of theproximal section 40 of the catheter shaft 36. In use, the guide wireport 26 communicates with the shaft opening 76 (see FIGS. 5 and 6) forproviding access to the guide wire channel. As such, the guide wire port26 may be positioned proximate or near the proximal end 30 of thecatheter 24 or may be disposed further distally of the proximal end 30along the catheter 24 toward the optional taper 48, depending on thelocation of the shaft opening. Although it should be recognized that theguide wire port 26 may be located at any location distally of theproximal end 30 of the catheter 24, in one embodiment it is locatedapproximately between 140 and 180 centimeters from the taper 48.

Referring now to FIGS. 5 and 6, one exemplary embodiment of the guidewire port 26 is shown in more detail. As best shown in the embodimentsof FIGS. 5 and 6, the guide wire port 26 may include a main body 86 anda funnel-shaped extension 88. The funnel-shaped extension 88 isconnected to and disposed adjacent the main body 86. The main body 86includes a main channel 90 extending therethrough. The main channel 90is sized to accommodate the catheter shaft 36 in a slidably restrictingmanner. Once positioned on the catheter shaft 36 in a suitable position,the guide wire port 26 is fixedly secured to the catheter shaft 36.

In the embodiment shown in FIGS. 5 and 6, the funnel-shaped extension 88includes a funnel channel 92 having a proximal opening 94 and a distalopening 96. In several embodiments, the proximal opening 94 of thefunnel channel 92 may be dimensioned significantly larger than the guidewire to be used with the catheter so that the guide wire may be easilyinserted into the funnel channel 92. The distal opening 96 of the funnelchannel 92 is positioned and sized to communicate with the guide wirechannel 60 of the catheter shaft 36, as will be described in more detailbelow, so that the guide wire may be inserted into the funnel channel 92through the proximal opening 94 and into the guide wire channel 60through the distal opening 96. The distal end of the main body 86 andthe distal portion of the funnel-shaped extension 88 converge togetherto define a merged section 100. The main channel 90 and the funnelchannel 92 also merge together into a merged channel 102 in the mergedsection 100. The funnel-shaped extension 88 further includes a slot orslit 104 for providing access to the funnel. channel 92. The slot 104extends along the length of the funnel-shaped extension 88 and thedistal merged section 100. The slot 104 is sized to allow passage of aconventional guide wire therethrough.

When assembled, the slot 104 of the guide wire port 26 is substantiallyaligned with the slot 78, the slit, or other means for allowing a guidewire to radially exit the guide wire channel 60, as shown in theembodiment of FIGS. 5 and 6. Additionally, the shaft opening 76 isaligned with and is dimensioned to correspond to the distal opening 96of the tunnel channel 92 for communication therebetween. As such, therapid exchange channel section and the guide wire port 26 allows rapidexchange of either the guide wire or of the catheter 24 when analternative catheter or guide wire is desired during certain medicalprocedures. Additionally, shorter length guide wires, such as 260centimeter guide wires, may be used since the guide wire does not needto pass though the proximal end of the catheter shaft 36. Alternatively,it will be appreciated that such a catheter shaft construction as shownand described herein also allows for longer length guide wires, such asthe conventional 450 centimeter guide wires, to be routed from theproximal end 30 of the catheter shaft 36 to the distal end 32 of thecatheter shaft 36, and beyond.

In exemplary embodiments of the present invention, the catheter shaft 36may have one or more of the following dimensions. For example, theproximal section 40 may be approximately 200-240 centimeters in lengthand have an outside diameter of approximately 12 French. In thisembodiment, the outer diameter of the core body 80 is approximately0.125 inches. The core body 80 may house a working channel 60 having adiameter of approximately 0.054 inches, an optical channel 62 having adiameter of approximately 0.044 inches, an irrigation channel 66 havinga diameter of approximately 0.032 inches, a guide wire channel 64 havinga diameter of approximately 0.040 inches (for use with a 0.035 inchdiameter guide wire), and four steering wire channels 70 each having adiameter of approximately 0.012 inches. The core body 80 may be sheathedwith an outer sleeve 82 having a thickness of approximately 0.006-0.012inches. Alternatively, the core body can remain unsheathed and have anouter diameter of approximately 11-12 French. It will be appreciatedthat the aforementioned dimensions may have tolerances of approximately0.002 inches.

The distal section 44 may be approximately 10-40 centimeters in lengthand have an outside diameter of approximately 11 French. In thisembodiment, the outer diameter of the core body 80 is approximately0.125 inches. The dimensions of the aforementioned channels aresubstantially identical. The core body 80 may be sheathed. with areinforcement layer 84 and an outer sleeve 82. The reinforcement layer84 has a thickness of approximately 0.0035 inches and the outer sleeve82 has a thickness of approximately 0.006 inches. Alternatively, thedistal section of the core body can omit the reinforcement layer andouter sleeve, and have an outer diameter of approximately 10-11 French.It will be appreciated that the aforementioned dimensions may havetolerances of approximately 0.002 inches.

In other embodiments, such as those illustrated in FIGS. 7-9, theoutside diameter of the proximal section core body 80 may beapproximately 0.145 inches or around 11 French. The core body 80 of theproximal section 40 in this embodiment may also be encased with an outersleeve 82 of approximately 0.006 inch thickness, resulting in an outerdiameter of the shaft of approximately 12 French. In this embodiment,the outer diameter of the core body 80 of the distal section 44 isapproximately 0.125 inches, and may include a reinforcement layer (notshown) of approximately 0.0035 inch thickness and/or an outer sleeve 82of approximately 0.006 inch thickness. Alternatively, the proximalsection of the core body can remain unsheathed and have an outerdiameter of approximately 12 French, and the distal section of the corebody can remain unsheathed and unreinforced and have an outer diameterof approximately 11 French.

In yet other embodiments, the catheter may be used with an 0.025 inchdiameter guide wire. As such, the diameters of the internal channels maybe adjusted so that the overall outer diameter of the catheter isreduced. For example, in this embodiment, the outer diameter of the corebody 80 may be approximately 0.115 inches. The core body 80 may house aworking channel 60 having a diameter of approximately 0.054 inches, anoptical channel 62 having a diameter of approximately 0.040 inches, anirrigation channel 66 having a diameter of approximately 0.030 inches, aguide wire channel 64 having a diameter of approximately 0.030 inches,and four steering wire channels 70 each having a diameter ofapproximately 0.012 inches. The core body 80 may be sheathed with anouter sleeve 82 having a thickness of approximately 0.050 inches.Accordingly, the outside diameter of the catheter is approximately 0.125inches, or slightly less than 10 French. It will be appreciated that theaforementioned dimensions may have tolerances of approximately 0.002inches. It will further be appreciated that in this embodiment, theouter sleeve 82 may have a thickness of approximately 0.010-0.012 incheson the proximal section to increase stiffness, etc, resulting in aproximal section having an outer diameter of approximately 11 French.

Returning to the embodiment of FIG. 1, the catheter 24 may befunctionally connected to the catheter handle 22. FIG. 1 illustrates oneexemplary embodiment of a catheter handle that may be practiced withembodiments of the catheter 24, although many others may bealternatively used. As best shown in FIG. 1, the handle 22 includes ahandle housing 106 to which a steering mechanism 108, one or more ports,and an optional endoscope attachment device (not shown) is operativelyconnected. The one or more ports may include any combination of aworking channel port 112 for providing access to the working channelfrom the proximal end of the catheter 24, an optical channel port 114for providing access to the optical channel from the proximal end of thecatheter 24, and a fluid channel port 116 for providing access to theirrigation/insufflation channel from the proximal end of the catheter24. The catheter handle 22 may include an optional guide wire port 118for providing access to the guide wire channel from the proximal end ofthe catheter 24.

While the ports 112, 114, and 116 are shown on the handle 22, it will beappreciated that ports for accessing the one or more channels of thecatheter shaft may additionally or alternatively be disposed anywherealong the catheter shaft, preferably somewhere along the proximalsection.

The steering mechanism 108 of the catheter handle 22 controls deflectionof the distal end 32 of the catheter 24. The steering mechanism 108 maybe any known or future developed mechanism that is capable of deflectingthe distal end of the catheter by selectively pulling the steeringwires. In the embodiment shown in FIG. 1, the steering mechanism 108includes two rotatable knobs for effecting 4-way steering of thecatheter distal end in the up/down direction and in the right/leftdirection. This mechanism 108 includes an outer knob 110A to controlup/down steering and an inner knob 110B to control right/left steering.Alternatively, the inner knob 110B may function to control right/leftsteering and an outer knob 110A may function to control up/downsteering. The knobs interface with the distal end 32 of the catheter 30via the steering wires 72 (See FIG. 4) that extend through the catheter24.

While a manually actuated steering mechanism for effecting 4-waysteering of the distal is shown, it will be appreciated that a manuallyactuated steering mechanism that effects 2-way steering may be practicedwith and is therefore considered to be within the scope of the presentinvention. Please see co-pending U.S. application Ser. No. 11/089,520,which is hereby incorporated by reference, for a more detaileddescription of steering mechanisms that may be practiced with thepresent invention. In embodiments of the catheter handle that connect tonon-steerable catheters, it will be appreciated that the steeringmechanism may be omitted from the handle.

In use, various treatment or diagnostic devices, such as stone retrievalbaskets, lasers, biopsy forceps, etc. may be inserted into the workingchannel port 112 of the catheter handle 22 and routed to the treatmentarea located distally of the catheter distal end. Optical devices, suchas vision catheters or fiberscopes, may be inserted into the opticalchannel port 114 of the catheter handle 22 and routed to the treatmentarea located distally of the catheter distal end. Fluids, such asliquids or gases, may be injected into the fluid port 116 and deliveredto the distal end of the catheter. Finally, a guide wire may be insertedinto the optional guide wire port or working channel port if desired,and routed to the treatment area located distally of the catheter distalend.

For examples of imaging devices that may be practiced with embodimentsof the present invention, please see the description of the fiber opticcable in co-pending U.S. application Ser. No. 10/914,411, filed Aug. 9,2004, the fiberscope and methods of use in co-pending U.S. applicationSer. No. 11/089,520, and the guide wire scope described in U.S.Published Patent Application Number 2004/0034311 A1, the disclosures ofwhich are hereby incorporated by reference.

Turning now to FIGS. 10-13, there is shown another representativeembodiment of a catheter assembly, generally designated 120. Thecatheter assembly 120 is substantially identical in construction,materials, and operation as the catheter assembly 20, except for thedifferences that will now be described. As best shown in FIG. 10, thecatheter assembly 120 may include a catheter handle 22, a catheter 124,and a guide wire port 126 position along a portion of the catheter 124.The catheter 124 includes a proximal end 130 that may be operativelyconnected to the catheter handle 22 and a distal end 132 that may beinserted into, for example, a working channel of an endoscope or apassageway of a patient.

The catheter 124 includes a shaft 136 having a generallycylindrically-shaped body of substantially uniform diameter. The shaft136 comprises a proximal section 140 and a distal section 144. Inseveral embodiments, the distal section 144 or portions thereof may beconstructed to be more flexible or bendable so that the distal end 132of the catheter shaft 136 may be steered in one or more directionsduring use.

Turning now to FIG. 11, there is shown an end view of the catheter shaft136 positioned within a working channel WC of an endoscope.Substantially similar to the catheter shaft 36 of FIGS. 2-4, thecatheter shaft 136 may define an optical channel 162 and a workingchannel 164 that extend the length of the catheter from its proximal end130 to its distal end 132. The shaft 136 also includes a dedicated guidewire channel 160 that extends the entire length of the catheter 124through which a guide wire can be routed to and from the treatment area.However, in contrast to the catheter shaft 36 shown in FIG. 3 anddescribed above, the rapid exchange section of the catheter shaft 36 isomitted. The shaft 136 may further include an additional channel 166that extends the entire length of the catheter shaft 136 for use as anirrigation/insufflations channel or fluid delivery channel.

In one embodiment, the catheter shaft may be constructed of a core body180, an outer sleeve 182, and an inner reinforcement sheath 184. Theinner reinforcement sheath 184 is disposed in-between the core body 180and the outer sleeve 182, as best shown in FIG. 12, and functions toprovide increased column strength and torsional rigidity. The innerreinforcement sheath 184 and outer sleeve 182 extend along the cathetershaft 136 from the proximal end 130 to the distal end 132, or portionsthereof.

Finally, the catheter shaft may include an opening 176 formed along aportion of the outer surface of the shaft and positioned, for example,near or at the beginning of the distal section, as best shown in FIG.13. The opening 176 is formed so as to communicate with and provideaccess to the guide wire channel 164 from a position that is external tothe shaft. As such, the opening 176 in the embodiment shown is formedthrough the outer sleeve 182, the reinforcement sheath 184 (not shown inFIG. 13 for ease of illustration), and a portion of the core body 180.As will be described in detail below, the opening 176 communicates withthe guide wire port 126 for facilitating the insertion of a guide wireinto the guide wire channel during use.

Returning to FIG. 10, the catheter 124 further includes a guide wireport 126 positioned near or at the beginning of the distal section 144for providing access to a guide wire channel of the catheter shaft 136.In one embodiment, the guide wire port is located approximately between5 and 30 centimeters from the distal end of the catheter shaft. In thatregard, shorter guide wires, such as those approximately 260 cm to 450cm, may be employed by the catheter 124. Referring now to FIG. 13, theguide wire port 126 is shown in more detail. As best shown in FIG. 13,the guide wire port 126 includes an extension section 188 and anoptional deflector 198. The extension section 180 is disposed adjacentthe catheter shaft 136. In several embodiments of the present invention,the guide wire port 126 can be constructed as a section of the outersleeve 182.

The extension 188 includes a channel 192 having a proximal opening 194and a distal opening 196. The proximal opening 194 of the channel 192 ispreferably larger than the distal opening 196 to form a somewhatfunnel-like channel. It will be appreciated that the proximal opening194 of the guide wire port 126 is constructed as large as possible sothat the guide wire GW may be easily inserted into the channel whilealso allowing the catheter shaft 136 to be inserted into a standard 4.2mm inside diameter endoscope working channel WC as best shown in FIG.11. The distal opening 196 of the channel 192 is positioned and sized tocommunicate with the shaft opening 176, and in turn, the guide wirechannel 164 of the catheter shaft 136 so that the guide wire GW may beinserted into the guide wire channel 164 through the distal opening 196and shaft opening 176.

The guide wire port 126 may be further formed with an optional deflector198. In one embodiment, the deflector 198 is positioned to inwardlyextend into the shaft opening 176 and a substantial portion of the guidewire channel 160. The deflector 198 is operable to pivot about area 200so as to either be capable of blocking access to the guide wire channel164 of the catheter shaft 136 or the guide wire port channel 192. Inseveral embodiments, the deflector 198 is inwardly biased to theposition shown in FIG. 13. In this position, a guide wire may be frontloaded into either the optional guide wire port 118 on the catheterhandle 22 (see FIG. 10) and routed through the catheter shaft to thedistal end of the catheter or inserted into the guide wire port proximalopening 194 and routed to the distal end of the catheter. It will beappreciated that in this embodiment, if routed down the guide wire porton the handle, the guide wire would temporarily displace the deflectorso that the guide wire could pass through.

Once the guide wire is removed, the deflector 198 is again biased to theposition in FIG. 13. In this manner, the catheter is also back loadable.For example, when the catheter is routed over a guide wire previouslyplaced within a body channel, the guide wire enters the distal endopening 196 of the guide wire channel 192 and then is routed through theguide wire port channel 192 as a result of the deflector 198. It willalso be appreciated that the deflector 198 could be biased in a positionthat blocks the distal opening 196 of the guide wire port channel 192 sothat the back loadable guide wire is routed through the guide wirechannel 160 to the catheter's proximal end and out of the optional guidewire port of the catheter handle.

In exemplary embodiments of the present invention, the catheter 124 mayhave one or more of the following dimensions. For example, the proximalsection 140 may be approximately 200-240 centimeters in length and havean outside diameter of approximately 10 French. The distal section 144may be approximately 10-40 centimeters in length and have an outsidediameter of approximately 10 French. In this embodiment, the outerdiameter of the core body 180 is approximately 0.118 inches. The corebody 180 may house a working channel 160 having a diameter ofapproximately 0.050 inches, an optical channel 162 having a diameter ofapproximately 0.042 inches, an irrigation channel 166 having a diameterof approximately 0.030 inches, a guide wire channel 164 having adiameter of approximately 0.040 inches (for use with a 0.035 inchdiameter guide wire), and four steering wire channels 170 each having adiameter of approximately 0.012 inches. The core body 180 may besheathed with a reinforcement layer 184 and an outer sleeve 182. Forexample, a reinforcement layer 184 may be employed having a thickness ofapproximately 0.0035 inches and the outer sleeve 182 may be employedhaving a thickness of approximately 0.0035 inches. It will beappreciated that the aforementioned dimensions may have tolerances ofapproximately 0.002 inches.

Turning now to FIGS. 14-17, there is shown another representativeembodiment of a catheter assembly, generally designated 220. Thecatheter assembly 220 is substantially identical in construction,materials, and operation as the catheter assembly 20, except for thedifferences that will now be described. The catheter assembly 220 mayinclude a catheter handle 22, a catheter 224, and a guide wire port 226positioned along a portion of the proximal section of catheter 224. Thecatheter 224 includes a proximal end 230 that may be operativelyconnected to the catheter handle 22 and a distal end 232 that may beinserted into, for example, a working channel of an endoscope or apassageway of a patient. The catheter 224 includes a shaft 236comprising a proximal section 240, a distal section 244, and a taper248, which acts as a transition between the proximal section 240 and thedistal section 244 of the catheter 224. In several embodiments, thedistal section 214 or portions thereof may be constructed to be moreflexible or bendable so that the distal end 232 of the catheter shaft236 may be steered in one or more directions during use,

Turning now to FIGS. 15 and 16, there are shown cross-sectional views ofthe proximal section 240 taken distally of the guide wire port 126 andthe distal section 144, respectively. Substantially similar to thecatheter shaft 36 of FIG. 3, the catheter shaft 236 may include anoptical channel 262 and a working channel 264 that extend the length ofthe catheter or portions thereof. The shaft 236 may also include anadditional channel 266 for use as an irrigation/insufflations channel orfluid delivery channel. The shaft 236 further includes a dedicated guidewire channel 260 that extends the entire length of the catheter throughwhich a guide wire can be routed to and from the treatment area. Theguide wire channel 260 includes a slot 278 from the guide wire port 226to the beginning of the taper of the catheter shaft 236 as shown in FIG.16. As described in more detail above, other means for accessing theguide wire channel may be employed, including those shown in FIGS. 18and 19.

As best shown in FIGS. 15 and 16, the shaft may be constructed of a corebody 280, an outer sleeve 382, and an inner reinforcement sheath 284disposed in-between the core body 280 and the outer sleeve 282 forproviding improved column strength and torsional rigidity. The innerreinforcement sheath 284 and outer sleeve 282 extend along the cathetershaft from the proximal end to the distal end, or portions thereof. Theouter sleeve 282 in this embodiment forms the slotted channel section asit extends from the guide wire port 226 to the taper 248. At the taper248, the slot 278 of the guide wire channel 260 terminates and the guidewire channel 260 merges gradually into the core body 280 of the cathetershaft, as best shown in FIG. 17. It will be appreciated that in thisportion of the catheter shaft, the reinforcement sheath 284 is omittedor an aperture is created so that the guide wire channel 260 cantransition from being disposed outside of the core body 280, as bestshown in FIG. 15, to being disposed inside the core body 280, as shownbest in FIG. 16.

In exemplary embodiments of the present invention, the catheter 224 mayhave one or more of the following dimensions. For example, the proximalsection 240 may be approximately 200-240 centimeters in length and havean outside width of approximately 0.147-0.1.55 inches and a height ofapproximately 0.132-0.135. The distal section 244 may be approximately10-40 centimeters in length and have an outside diameter ofapproximately 10-11 French. The core body 280 may house a workingchannel 260 having a diameter of approximately 0.054 inches, an opticalchannel 262 having a diameter of approximately 0.044 inches, anirrigation channel 166 having a diameter of approximately 0.030 inches,a guide wire channel 164 having a diameter of approximately 0.030-0.040inches (depending on use of a 0.025 or 0.035 inch diameter guide wire),and four steering wire channels 170 each having a diameter ofapproximately 0.012 inches. The core body 180 may be sheathed with areinforcement layer 184 and an outer sleeve 182. In these embodiments,the reinforcement layer 284 has a thickness of approximately 0.0035inches and the outer sleeve 282 has a thickness of approximately 0.0035inches. It will be appreciated that the aforementioned dimensions mayhave tolerances of approximately 0.002 inches.

The principles, representative embodiments, and modes of operation ofthe present invention have been described in the foregoing description.However, aspects of the present invention which are intended to beprotected are not to be construed as limited to the particularembodiments disclosed. Further, the embodiments described herein are tobe regarded as illustrative rather than restrictive. It will beappreciated that variations and changes may be made by others, andequivalents employed, without departing from the spirit of the presentinvention. Accordingly, it is expressly intended that all suchvariations, changes, and equivalents fall within the spirit and scope ofthe present invention, as claimed.

1-25. (canceled)
 26. A method for positioning a guide wire in a medicaldevice, the method comprising: positioning a proximal section of theguide wire exteriorly of a proximal section of a shaft of the medicaldevice; positioning an intermediate section of the guide wire such thatthe intermediate section of the guide wire radially accesses anintermediate section of the shaft, wherein the intermediate section ofthe guide wire extends radially between an exterior of the shaft and aninterior of the shaft through a discontinuity in the intermediatesection of the shaft, wherein the discontinuity is in an outer sleeve ofthe shaft, wherein the interior of the shaft includes a guide wirechannel extending through a core body of the shaft, the guide wirechannel receiving the guide wire, and wherein the outer sleeve isfixedly attached to the core body such that an outer surface of the corebody engages an inner surface of the outer sleeve; and positioning adistal section of the guide wire within a distal section of the shaft,wherein the distal section of the guide wire is routed through the guidewire channel between the discontinuity and a guide wire opening at adistal end of the shaft.
 27. The method of claim 26, further includingdeflecting the distal end of the shaft using at least one steering wireextending through the shaft.
 28. The method of claim 26, whereinpositioning the intermediate section of the guide wire includesinserting the guide wire through the discontinuity, the discontinuityincluding a slot, wherein the slot and the guide wire channel define aslotted channel section, and wherein the slot includes substantiallyparallel edges separated by a gap.
 29. The method of claim 28, whereinthe guide wire transitions between the interior of the shaft and theexterior of the shaft where the slotted channel section terminates, asthe guide wire channel transitions from being disposed outside of thecore body to being disposed inside of the core body.
 30. The method ofclaim 26, wherein the distal section of the guide wire is routed throughan intermediate sleeve disposed radially between the core body and theouter sleeve at the distal section of the shaft, and wherein a proximalend of the intermediate sleeve terminates distally of a proximal end ofthe discontinuity.
 31. The method of claim 26, wherein positioning theintermediate section of the guide wire includes passing the intermediatesection of the guide wire through a guide wire port fixedly secured tothe intermediate section of the shaft, and wherein the guide wire portincludes a funnel-shaped extension for guiding the guide wire.
 32. Themethod of claim 31, further comprising inserting the guide wire throughthe funnel shaped extension before inserting the guide wire through thediscontinuity.
 33. A method for positioning a guide wire in a medicaldevice, the method comprising: positioning a proximal section of theguide wire exteriorly of a proximal section of a shaft of the medicaldevice; positioning an intermediate section of the guide wire such thatthe intermediate section of the guide wire radially accesses anintermediate section of the shaft, wherein the intermediate section ofthe guide wire passes radially between an exterior of the shaft and aninterior of the shaft through a slot in the intermediate section of theshaft, wherein the slot is in an outer sleeve of the shaft, wherein theinterior of the shaft includes a guide wire channel extending through acore body of the shaft, the guide wire channel receiving the guide wire,and wherein the outer sleeve covers the core body; and positioning adistal section of the guide wire within a distal section of the shaft,wherein the distal section of the guide wire is routed through the guidewire channel between the slot and a guide wire opening at a distal endof the shaft, such that the distal section of the guide wire passesthrough an intermediate sleeve disposed radially between the outersleeve and the core body, and wherein a proximal end of the intermediatesleeve terminates distally of a distal end of the slot, such thatinterference between the intermediate section of the guide wire and theintermediate sleeve is avoided.
 34. The method of claim 33, furtherincluding sliding the distal section of the guide wire through thedistal section of the shaft, while the outer sleeve locks theintermediate sleeve in place and secures the intermediate sleeve to thecore body.
 35. The method of claim 33, further including sliding theguide wire through a portion of the slot in the core body.
 36. A methodfor positioning a guide wire in a medical device, the method comprising:inserting the guide wire through an aperture of a channel in a shaft ofthe medical device, the channel defining a passageway between an outersurface of an outer sleeve of the shaft and a longitudinally-extendingguide wire lumen within the shaft; engaging a moveable member of theshaft with the guide wire during insertion of the guide wire through theaperture, wherein the moveable member is configured to move between afirst position and a second position, the moveable member being closerto the aperture in the first position than in the second position; androuting the guide wire through a portion of the guide wire lumen distalto the channel.
 37. The method of claim 36, wherein engaging themoveable member includes deflecting the moveable member against abiasing force acting on the moveable member.
 38. The method of claim 36,wherein engaging the moveable member includes deflecting the guide wireas the guide wire is forced against the moveable member.
 39. The methodof claim 36, wherein movement of the moveable member between the firstand second positions opens a path between the channel and the portion ofthe guide wire lumen distal to the channel.
 40. The method of claim 36,wherein movement of the moveable member between the first and secondpositions closes a path between the channel and the portion of the guidewire lumen distal to the channel.